THIS RFA REPLACES AND SUPERSEDES RFA-HL-02-004, WHICH APPEARED IN THE NIH
GUIDE ON OCTOBER 15, 2001.
INNOVATIVE CONCEPTS AND APPROACHES TO DEVELOPING FUNCTIONAL TISSUES AND ORGANS
FOR HEART, VASCULAR, LUNG, AND BLOOD APPLICATIONS: EXPLORATORY/DEVELOPMENTAL
(R21) RESEARCH GRANTS
Release Date: December 3, 2001
RFA: RFA-HL-02-017
National Heart, Lung, and Blood Institute
(http://www.nhlbi.nih.gov )
Letter of Intent Receipt Date: January 21, 2002
Application Receipt Date: February 20, 2002
THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR
INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS REQUESTING LESS THAN
$250,000 PER YEAR IN ALL YEARS. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN
SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT
http://grants.nih.gov/grants/funding/phs398/phs398.html.
PURPOSE
The intent of this solicitation is to encourage innovative research leading to
the development of new approaches, technologies, tools, methods, devices,
cells, biomolecules, and biomaterials that can be used to either engineer
tissue in vitro as a biological substitute for implantation or to foster
tissue regeneration in vivo, with the purpose of replacing, repairing,
maintaining, or enhancing organ function.
HEALTHY PEOPLE 2010
The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This Request for Applications (RFA),
Innovative Concepts and Approaches to Developing Functional Tissues and Organs
for Heart, Vascular, Lung, and Blood Applications: Exploratory/Developmental
Awards (R21), is related to one or more of the priority areas. Potential
applicants may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople/.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic and foreign, for-profit and non-
profit organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and eligible
agencies of the Federal government. Racial/ethnic minority individuals,
women, and persons with disabilities are encouraged to apply as Principal
Investigators.
The use of human embryonic stem cells will be allowed in accordance with the
NIH guidelines for applications requesting funding that proposes research with
human embryonic stem cells which can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-006.html. Principal
investigators and their applicant institutions are urged to read this guidance
carefully and follow the steps outlined. In addition, up-to-date information
regarding these guidelines is provided in the form of frequently asked
questions at http://grants.nih.gov/grants/stem_cell_faqs.htm.
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH) Exploratory/
Developmental Research Grant (R21) award mechanism. Responsibility for the
planning, direction, and execution of the proposed project will be solely that
of the applicant. The total project period for an application submitted in
response to this RFA may not exceed three years. This RFA is a one-time
solicitation. The R21 cannot be renewed: if sufficient data are generated
during the term of the award, investigators could apply for further funding
through regular research grant mechanisms, e.g. the research project grant
(R01) mechanism. The anticipated award date is September 30, 2002.
Specific application instructions have been modified to reflect "MODULAR
GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the
NIH. Complete and detailed instructions and information on Modular Grant
applications have been incorporated into the PHS 398 (rev. 5/2001).
Additional information on Modular Grants can be found at
http://grants.nih.gov/grants/funding/modular/modular.htm.
FUNDS AVAILABLE
The NHLBI intends to commit approximately $6,750,000 in FY 2002 to fund 30 new
grants in response to this RFA. An applicant may request a project period of
up to three years and a budget for direct costs of up to $150,000, or six
modules, per year. Because the nature and scope of the research proposed may
vary, it is anticipated that the size of each award will also vary. Although
the financial plans of the NHLBI provide support for this program, awards
pursuant to this RFA are contingent upon the availability of funds and the
receipt of a sufficient number of meritorious applications. The new National
Institute of Biomedical Imaging and Bioengineering (NIBIB) also has a strong
interest in this area of research. The NIBIB will consider support of
applications submitted in response to this RFA after the Institute's
accounting structures have been set up.
RESEARCH OBJECTIVES
Background
Every day thousands of people of all ages are admitted to hospitals because of
the malfunction of some vital organ. Estimates of the total U.S. health care
costs for patients with tissue loss or end-stage organ failure exceed $400
billion annually. Until very recently, most damaged or diseased human tissue
could only be replaced by donor transplants or with totally artificial parts.
Both of these solutions are imperfect, in part, because of the dearth of
transplantable organs and the risks associated with prosthetic replacements.
Today, tissue engineering and regenerative medicine promise to revolutionize
the treatment of patients who need new vital structures. These approaches
apply the principles of engineering and the life sciences in an effort to
reach a fundamental understanding of structure-function relationships in
normal and pathological tissues and to develop biological substitutes, with
the capacity to grow and remodel, to restore, maintain, or improve tissue and
organ function. The field has already made headway in the
synthesis/regeneration of structural tissues such as skin, cartilage, and
bone. Furthermore, bladders have been successfully bioengineered and
implanted in dogs. Thus, progress to date predicts future success in the
bioengineering of more complex internal organs and the field is now poised for
moving ahead in that direction. However, high risk, innovative research in
some critical areas could serve as a catalyst for engineering functional
cardiovascular, lung, and blood tissues and help lay the foundation for
success that could impact tremendously on human health.
Scope
This RFA is being issued in recognition of the nascence of this scientific
area for heart, lung, and blood applications, and the need for the development
of novel concepts and approaches to engineering or regenerating functional
tissues and organs. The primary purpose of the solicitation is to provide
investigators with the opportunity to explore entirely new approaches and test
imaginative new ideas in areas that will have a significant impact on
developing functional cardiovascular, lung, and blood tissues and organs
through fabrication of engineered constructs in vitro or by regeneration and
remodeling in vivo. In addition, it is intended to encourage the development
of substantial and meaningful changes to existing technology. The proposed
research should be at the frontiers of tissue engineering and regenerative
medicine, it should be unusually imaginative or dramatically different from
past paradigms, and it must have the potential for a broad impact on current
efforts directed at growing tissues for repair or replacement. To be eligible
for consideration, proposals must be distinct from those traditionally
submitted through the R01 mechanism. For example, projects designed to
produce incremental advances in knowledge will not be considered. Proposals
submitted under this mechanism should be limited to those with the potential
for truly ground-breaking impact.
Since the R21 mechanism is intended to encourage exploratory research, no
preliminary data are required. However, the application should make clear
that the proposed research is scientifically sound, the qualifications of the
investigators are appropriate, and the resources available to the
investigators are adequate. Applications from both individuals and groups
interested in developing suitable novel approaches are encouraged, however
team approaches to these efforts are especially encouraged in the belief that
a synergistic blend of expertise and resources may be needed. It is expected
that this research will require expertise from a variety of disciplines,
including engineering, chemistry, physics, materials science, biology, and
medicine.
Efforts in cardiovascular, lung, and blood tissue engineering and regenerative
medicine share many common scientific challenges and can benefit from some
common technological approaches. At the same time, each application area also
presents its own challenges that relate to specific clinical problems and the
unique biology and physiology of the tissue. Research under this program
should thus proceed along one, or both, of two parallel fronts; cross-cutting
basic science and technology and/or focused approaches aimed at well-defined
clinical problems. The NHLBI anticipates the receipt of applications
addressing, but not limited to, the following areas:
1. Basic Science and Technology Common to Heart, Lung, and Blood
A. Stem/Progenitor Cell Biology B Studies focused on heart, vascular, lung,
and blood stem/progenitor cells is needed including: 1) molecular
identification of stem/progenitor cells; 2) development of cellular markers to
distinguish stem/progenitor cells; 3) study and improvement of stem/progenitor
cell homing; 4) understanding growth factors, matrix molecules, and signaling
pathways involved in stem/progenitor cell growth and differentiation; 5)
development of standard protocols for culturing stem/progenitor cells
B. Vascular Assembly in Engineered and Natural Tissues - Research in at least
two major areas is needed: 1) for cells or patches of tissue implanted
directly into a site in vivo or for tissue regenerated in vivo; analysis of
the spacial and temporal interplay of multiple genetic and environmental
signals involved in the development, regeneration, and regression of vascular
networks; 2) for tissues grown in vitro; methods to create vascular networks
ranging from capillaries to arteries/veins that are capable of anastomosing
with vessels at the site of implantation.
C. Signaling and Remodeling B Knowledge of the interplay between
environmental factors and intrinsic cell factors that together regulate
renewal of cardiovascular, lung, and blood tissues is needed including: 1)
understanding what environmental cues, including growth factors and matrix
molecules, attract the cells that ultimately lead to repopulation of sites of
injury and identification of where such cells originate; 2) understanding the
factors that prevent regeneration of injured structures; and 3) developing
quantitative analyses and modeling of how signals are presented physically and
temporally to cells and how cells integrate multiple signals to generate a
response. This knowledge could provide a design basis for the manipulation of
the environment to achieve tissuegenesis.
D. Scaffold Fabrication and Control of Cellular Behavior - Techniques for
creating 3D scaffolds with complex architecture and chemistry must be
developed significantly beyond current stages to address the needs of
vascularized and innervated tissues. This includes development of novel
molecular design strategies, materials fabrication processes, and methods for
functional analysis of biomaterials.
Highly novel research focused on genetic approaches to tissue engineering,
regeneration, and repair, innervation of tissue-engineered/regenerated tissue,
functional assessment of engineered/regenerated tissue, issues related to the
immune response to engineered tissues and cells, and bioreactors and
bioprocessing, will also be considered responsive.
2. Functional Applications of Science and Technology to Clinical Problems
A. Heart B Engineer cells, myocardial patches, or heart ventricles for
implantation to restore, renew or replace the contractile function of the
failing heart. Tissue engineer valves to treat congenital or acquired
diseases of the heart valves and great arteries. Develop biomechanical
environments for engineering cardiac tissues in vitro. Design methods to
foster cardiac tissue regeneration in vivo.
B. Vascular B Efforts to develop tissue-engineered vascular grafts with
improved long-term patency need to be undertaken particularly with the
addition of physiologically relevant mechanical forces to the growing tissue.
Design methods to foster vascular regeneration in vivo.
C. Lung B Novel approaches such as using progenitor cells or patches of
cultured primordial lung tissue to replace gas exchange areas destroyed by
injury and replaced by dysfunctional tissue. Effects of mechanical factors on
function of newly generated or transplanted tissues will need to be assessed.
D. Blood B Hematopoietic stem cells: assays for stem cell products that
predict engraftment in patients, transplant regimens with reduced toxicity,
regimens that induce tolerance, methods to identify, purify, and expand
specific populations of lineage committed cells, and generation of "generic"
stem cell populations. Transfusable blood components: culture-derived red
blood cells, leukocytes, and platelets (or their precursors), artificial
oxygen carrying solutions, methods to prevent immunization by such cells or
artificial blood components, and large scale production and storage methods
are needed.
SPECIAL REQUIREMENTS
Grantees will meet annually to share results, to ensure that the NHLBI has a
coherent view of the advances in the field, and to have an opportunity for
collective problem solving among investigators. Applicants should request
travel funds in their budget for the principal investigator and one additional
young investigator to attend this annual meeting.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups and
their sub-populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided indicating
that inclusion is inappropriate with respect to the health of the subjects or
the purpose of the research. This policy results from the NIH Revitalization
Act of 1993 (Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the AMENDMENT "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research - Amended, October, 2001," published in the NIH Guide for Grants and
Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of
clinical research; updated racial and ethnic categories in compliance with the
new OMB standards; clarification of language governing NIH-defined Phase III
clinical trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable; and
b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them.
This policy applies to all initial (Type 1) applications submitted for receipt
dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the Inclusion of Children as Participants in
Research Involving Human Subjects that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html
Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS
NIH policy requires education on the protection of human subject participants
for all investigators submitting NIH proposals for research involving human
subjects. This policy announcement is found in the NIH Guide for Grants and
Contracts Announcement dated June 5, 2000, at the following website:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
URLS IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH
solicitation, internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT
The Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2) cited
publicly and officially by a Federal agency in support of an action that has
the force and effect of law (i.e., a regulation) may be accessed through FOIA.
It is important for applicants to understand the basic scope of this
amendment. NIH has provided guidance at:
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm
Applicants may wish to place data collected under this RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes a
descriptive title of the proposed research, the name, address, and telephone
number of the Principal Investigator, the identities of other key personnel
and participating institutions, and the number and title of the RFA in
response to which the application may be submitted. Although a letter of
intent is not required, is not binding, and does not enter into the review of
a subsequent application, the information that it contains allows IC staff to
estimate the potential review workload and plan the review.
The letter of intent is to be sent to Dr. Deborah Beebe, at the address listed
under INQUIRES, by the letter of intent receipt date listed in the heading of
this RFA.
APPLICATION PROCEDURES
The PHS 398 research grant application instructions and forms (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in
applying for these grants. This version of the PHS 398 is available in an
interactive, searchable format. Beginning January 10, 2002, the NIH will
return applications that are not submitted on the 5/2001 version. For further
assistance contact GrantsInfo, Telephone 301/435-0714, Email:
GrantsInfo@nih.gov.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS
The modular grant concept establishes specific modules in which direct costs
may be requested as well as a maximum level for requested budgets. Only
limited budgetary information is required under this approach. The
just-in-time concept allows applicants to submit certain information only when
there is a possibility for an award. It is anticipated that these changes will
reduce the administrative burden for the applicants, reviewers and NIH staff.
The research grant application form PHS 398 (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in
applying for these grants, with modular budget instructions provided in
Section C of the application instructions.
All application instructions outlined in the PHS 398 application kit are to be
followed with the following modifications for R21 applications:
1. R21 applications will use the "MODULAR GRANT" and "JUST-IN-TIME" concepts,
with direct costs requested in $25,000 modules, up to the total direct costs
limit of $150,000, or six modules, per year.
2. Items a-d of the Research Plan for the R21 application may not exceed 15
pages, including tables and figures. The following information should be
taken into account for items a, b and c:
o Item a, SPECIFIC AIMS--The instructions for this section suggest that the
applicant state "the hypotheses to be tested". Since some applications
submitted in response to this RFA may also be design- or problem-driven (e.g.,
development of novel technologies), or need-driven (initial research to
develop a body of data upon which future research will build), hypothesis
testing per se may not be the driving force in developing such a proposal and,
therefore, may not be applicable. Thus, the application should state the
hypotheses, design, problem and/or need which will drive the proposed
research.
o Item b, BACKGROUND AND SIGNIFICANCE--In this section, it is important to
identify clearly how the application addresses the specific objectives of this
RFA and the purpose of the R21 mechanism.
o Item c, PRELIMINARY STUDIES/PROGRESS REPORT-- Although preliminary data
are not required for an R21 application, they may be included.
The RFA label available in the PHS 398 (rev. 5/2001) application form must be
affixed to the bottom of the face page of the application. Type the RFA
number on the label. Failure to use this label could result in delayed
processing of the application such that it may not reach the review committee
in time for review. In addition, the RFA title and number must be typed on
line 2 of the face page of the application form and the YES box must be
marked. The RFA label is also available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
Submit a signed, typewritten original of the application, including the
Checklist, and three signed, photocopies, in one package to:
CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application, as well
as all five collated sets of Appendix material, must be sent to Dr. Deborah
Beebe at the address listed under Inquiries. Applications must be received by
the application receipt date listed in the heading of this RFA. If an
application is received after that date, it will be returned to the applicant
without review.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application. The
CSR will not accept any application that is essentially the same as one
already reviewed. This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications must include
an Introduction addressing the previous critique.
Principal investigators should not sent supplementary material without first
contacting the Scientific Review Administrator (SRA). The SRA will be
identified in the letter sent to you indicating that your application has been
received. If you have not yet received such a letter within three weeks after
submitting the application, contact Dr. Deborah Beebe at the address listed
under Inquiries.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NHLBI. Incomplete and/or non-responsive applications
will be returned to the applicant without further consideration.
Applications that are complete and responsive to the RFA will be evaluated for
scientific and technical merit by an appropriate peer review group convened by
the NHLBI in accordance with the review criteria stated below. As part of the
initial merit review, all applications will receive a written critique and
undergo a process in which only those applications deemed to have the highest
scientific merit, generally the top half of the applications under review,
will be discussed, assigned a priority score, and receive a second level
review by the NHLBI National Advisory Council.
Review Criteria
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments, reviewers will be asked to discuss the following aspects
of the application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. Each of these
criteria will be addressed and considered in assigning the overall score,
weighting them as appropriate for each application. Note that the application
does not need to be strong in all categories to be judged likely to have major
scientific impact and thus deserve a high priority score.
(1) Significance: Does this study address an important problem? If the aims
of the application are achieved, how will scientific knowledge be advanced?
What will be the effect of these studies on the concepts or methods that drive
this field?
(2) Approach: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
(3) Innovation: Does the project employ novel concepts, approaches or method?
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?
(4) Investigator: Is the investigator appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the principal investigator and other researchers (if any)?
(5) Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional
support?
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
o The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will also be
evaluated.
o The reasonableness of the proposed budget and duration in relation to the
proposed research.
o The adequacy of the proposed protection for humans, animals or the
environment, to the extent they may be adversely affected by the project
proposed in the application.
Schedule
Letter of Intent Receipt Date: January 21, 2002
Application Receipt Date: February 20, 2002
Peer Review Date: May/June 2002
Council Review: September 5-6, 2002
Earliest Anticipated Start Date: September 30, 2002
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o scientific merit (as determined by peer review)
o availability of funds
o programmatic priorities.
INQUIRIES
Inquiries concerning this RFA are encouraged. The opportunity to clarify any
issues or answer questions from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Cardiovascular
Christine A. Kelley, Ph.D.
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
Rockledge II, Room 9142
Bethesda, MD 20892-7940
Telephone: (301) 435-0513
FAX: (301)480-1335
Email: kelleyc@nhlbi.nih.gov
Lung
Mary Anne Berberich, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
Rockledge II, Room 10102
Bethesda, MD 20892
Telephone: (301) 435-0222
FAX: (301) 480-3557
Email: berberim@nhlbi.nih.gov
Blood
Phyllis Mitchell, M.S.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
Rockledge II, Room 10163
Bethesda, MD 20892-7950
Telephone: (301) 435-0481
FAX: (301) 480-1060
Email: mitchelp@nhlbi.nih.gov
Send letter of intent and 2 copies of the application and direct inquiries
regarding review issues to:
Deborah P. Beebe, Ph.D.
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7178 (MSC 7924)
Bethesda, MD 20892-7924 (20817 for Courier)
Telephone: (301) 435-0270
Fax: (301) 480-3541
Email: BeebeD@nhlbi.nih.gov
Direct inquiries regarding fiscal matters to:
Ms. Diane Drew
Grants Operations Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7157A, MSC 7926
Bethesda, Maryland 20892-7926
Telephone: (301) 435-0177
FAX: (301) 480-3310
Email: drewd@nhlbi.nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.837, 93,838, and 93.839. Awards are made under authorization of Sections
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)
and administered under NIH grants policies and Federal Regulations 42 CFR 52
and 45 CFR Parts 74 and 92. This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and promote the non-use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the
PHS mission to protect and advance the physical and mental health of the
American people.